Indivior files Canadian submission for opium use disorder treatment

Indivior has filed a new drug submission (NDS) with Health Canada's Therapeutic Drugs Directorate, it announced on Friday, for its ‘SUBLOCADE’ (buprenorphine extended-release) injection, for subcutaneous use for the treatment of moderate-to-severe opioid use disorder (OUD), as part of a complete treatment plan to include counseling and psychosocial support.

The FTSE 250 drugmaker said Health Canada had granted Priority Review status for SUBLOCADE on 6 April, and if approved, the treatment would be marketed by Indivior Canada.

“The Priority Review designation is an important acknowledgment by Health Canada of the potential for SUBLOCADE to help address the current unmet needs for patients living with opioid use disorder,” said Indivior chief executive Shaun Thaxter.

“Indivior looks forward to working closely with regulatory authorities to ensure SUBLOCADE, if approved, will be available as soon as possible to the Canadian treatment community to help address the current opioid public health crisis.”

In granting the Priority Review status for the SUBLOCADE NDS, Health Canada noted that opium use disorder was a serious, potentially life-threatening disorder, and that there was substantial evidence of the clinical efficacy of SUBLOCADE in the treatment of moderate to severe cases.

Health Canada also acknowledged that SUBLOCADE had the potential to yield improved efficacy through enhanced adherence, due to its monthly administration, the Indivior board noted.

“A Priority Review designation indicates Health Canada's goal to review the NDS within a shortened target of 180 calendar days,” the Indivior board explained.

“Priority Review designation may be granted to drug submissions intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating diseases or conditions for which there is substantial evidence that the overall benefit/risk profile is improved over existing therapies, preventatives or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada.”

The NDS submission of SUBLOCADE to Health Canada followed approval of the drug by the US Food and Drug Administration (FDA) on 30 November last year.